BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2850828 · Received November 21, 2012

    Report

    Report Number
    2017233-2012-00777
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THIS PT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3 DEPLOYMENT SYSTEM AND THE GORE DRYSEAL SHEATH. THE PHYSICIAN DEPLOYED THE TRUNK-IPSILATERAL LEG COMPONENT, CANNULATED THE CONTRALATERAL GATE AND WAS ADVANCING THE SHEATH INTO THE GATE. HOWEVER, THE GREY DILATOR WAS NOT FULLY ADVANCED INTO THE SHEATH. THEREFORE, THE TRANSITION BETWEEN THE DILATOR AND THE SHEATH MOVED THE TRUNK-IPSILATERAL LEG COMPONENT PROXIMAL OVER THE LEFT RENAL ARTERY. THE PHYSICIAN THEN ADVANCED A BALLOON INTO THE IPSILATERAL LIMB AND BALLOONED WHILST PULLING DOWN ON DEVICE. THE PHYSICIAN MANAGED TO MOVE THE DEVICE DISTALLY AND PERFUSION TO THE LEFT RENAL ARTERY WAS RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 10597855

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention